NDAINJECTIONINJECTABLEPriority Review
Approved
Feb 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
KETALAR (ketamine hydrochloride) by Pfizer is ketalar, a racemic mixture of ketamine, is a non-selective, non-competitive antagonist of the n-methyl-d-aspartate (nmda) receptor, an ionotropic glutamate receptor. First approved in 1970.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KETALAR is a racemic ketamine hydrochloride injection approved in 1970 as a non-selective, non-competitive NMDA receptor antagonist used primarily as an anesthetic and analgesic. It works by blocking glutamate signaling at the NMDA receptor, with its active metabolite norketamine contributing approximately one-third of the pharmacologic effect. The drug is administered by injection and is used across surgical, emergency, and off-label pain management settings.
LOE Approaching
Product approaching loss of exclusivity with competitive pressure at 30%; brand teams should expect declining market share and transition toward generic competition management.
Mechanism of Action
KETALAR, a racemic mixture of ketamine, is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. The major circulating metabolite of ketamine (norketamine) demonstrated activity at the same receptor with less affinity. Norketamine…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on KETALAR offers exposure to a legacy anesthetic franchise with significant off-label expansion potential in psychiatry and pain management, but also presents the challenge of managing a product in LOE transition with declining exclusivity. Career growth requires strategic thinking around lifecycle management, competitive positioning, and emerging indication development rather than traditional new drug launches.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.